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FDA 510(k)

MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS

K-Number: K862523 · 1986-08-01

ApplicantWalter Lorenz Surgical, Inc.
Decision Date1986-08-01
Product CodeEKW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS is the device name listed in this FDA 510(k) record. The listed applicant is Walter Lorenz Surgical, Inc.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862523. The device is classified under product code EKW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS?

MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K862523.

When did MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS receive FDA 510(k) clearance?

MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862523.

Who is the listed applicant for MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS?

The FDA 510(k) record lists Walter Lorenz Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS?

The FDA product code for MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS is EKW.

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Other records listing Walter Lorenz Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063386LORENZ ORTHODONTIC ANCHORAGE SYSTEMK063052LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATESK063506LORENZ STERNAL CLOSURE SYSTEMK062842TWIST DRILLK061384LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUMK042516OTOMIMIX

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Related Devices (Code: EKW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K871493DENTI-TRAY(TM)Advanced Medical, Inc.K870765CANNULATED INSTRUMENT CLEANERSTreace Medical, Inc.K831749ENDODONTIC BROACH(76EKN) BARBED BROACHUnion BranchK823489ENDODONTIC BROACH-BARBED BROACHUnion Broach, Div. Moyco Industries, Inc.K800292ENDEX BROACH, ENDODONTICIpco Corp.K760985HAND INSTRUMENTSAdp Intl., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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